The Link Between the Clinical Resting Heart Rate and Symp... | NCT02315313

Studies
The Link Between the Clinical Resting Heart Rate and Sympathetic Overactivation

NCT02315313

Sponsor

Ruijin Hospital

Status

Unknown status

Last Update Posted

Dec 11, 2014Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Cardiovascular Disease

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Dec 2, 2014

First Submission Date that Met QC Criteria

Dec 8, 2014

First Posted Date

Dec 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2014

Last Update Posted Date

Dec 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

It is a retrospective study with no products limitation to investigate the link between clinical resting HR and SOA. Use HR≤60bpm as control group, compare other three groups with the control group and find out the correlation between HR and SOA indexes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group1		RHR≤60bpm
group2		RHR 61-70bpm
group3		RHR 71-80bpm
group4		RHR >80bpm

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The difference of HRV, BPV, LF/HF between each groups	The difference on mean sympathetic overactivation related indexes such as HRV, BPV, LF/HF between groups	1min HR measure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of subject informed written or oral consent
Female and male aged≥ 20 to ≤ 80 years;
Records on mean clinical heart rate and SOA indexes were available.

Exclusion Criteria:

Participation in another clinical study with an investigational product during the last 6 months;
Drug intervention on heart rate 1 month prior to the inclusion;
Patients with missing data in the database from the Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

cardiovascular disease patient

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jiguang Wang, PHD	Contact	13764189476		wangjiguang2000@126.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided